Smiths Medical recalled certain sizes of its Portex oral/nasal endotracheal tubes because of a manufacturing defect that results in a smaller diameter, which could potentially lead to inadequate ventilation.
The FDA has classified this as a Class I recall, its most serious type, warning that continued use of affected devices could result in severe injury or death, according to a March 25 news release from the agency.
The recall includes tube sizes 2.0, 2.5, 3.0 and 3.5 millimeters which may not provide sufficient airflow and can increase risk of hypoxia, laryngeal swelling, cardiopulmonary arrest and organ failure.
Smiths Medical originally issued a correction March 10, advising customers to stop using the affected products, destroy or quarantine them and notify all potential users.
There have been eight injuries reported with this recall.
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